Information Technology Needs Assessment for the



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|S T P I | |

Information Technology Needs Assessment for the

NIH Technology Transfer Community

Final Report

June 2008

Christina Viola Srivastava

Christopher Hart, Ph.D.

Brian Zuckerman, Ph.D.

Science and Technology Policy Institute

1899 Pennsylvania Avenue, Suite 520

Washington, DC 20006

Table of Contents

Introduction 1

Background and Purpose 1

Approach and Methods 1

Structure of this Report 1

Technology Transfer Community, Existing IT Infrastructure, and Flow of Information 1

Technology Transfer Community Participants 1

Existing IT Infrastructure 1

Flow of Information 1

Areas of Perceived Need 1

1. No Net Loss of Functionality or Productivity 1

2. Improvements to Existing Data Systems 1

3. Improved Information Transfer 1

4. Policy and Process Issues 1

Analysis and Recommendations 1

Options for Meeting Need 1

Analysis of Options 1

Recommended Option 1

Introduction

1 Background and Purpose

Responsibility for technology transfer activities at the National Institutes of Health (NIH) is shared among the Technology Development Coordinators (TDCs) at each of the 27 Institutes and Centers (ICs) and the Office of Technology Transfer (OTT) of the Office of Intramural Research. The TDCs negotiate and retain administrative responsibility for technology transfer agreements that occur prior to an invention or discovery, such as Cooperative Research and Development Agreements (CRADAs), Material Transfer Agreements (MTAs), Clinical Trial Agreements (CTAs), and Confidential Disclosure Agreements (CDAs). Charged with managing the portfolio of intellectual property that results from IC intramural research, they are also responsible for reviewing Employee Invention Reports and deciding whether IC resources should be devoted to securing intellectual property protection for discoveries, inventions, and other products of government science. Meanwhile, OTT handles most of the administrative burden associated with the new technologies themselves, including making recommendations to the ICs regarding whether to pursue intellectual property protection, prosecution of patents, negotiation, execution, and enforcement of licensing agreements, and administration of royalties.

The diversity, interdependency, and sheer volume of the various technology transfer activities and relevant legal and regulatory obligations makes tracking and communication essential at all levels of the technology transfer enterprise. At present, however, there is considerable heterogeneity and little integration among the various information systems used by members of the technology transfer community. The TDCs rely on IC-specific information tracking systems that vary in sophistication from simple spreadsheets to complex knowledge management systems, while OTT maintains a separate knowledge management system of its own. Direct transfer of information among these systems is extremely limited. OTT shares critical information with the ICs through the web-enabled enterprise reporting application nVision, the output of which is not easily compatible with any of the IC systems. Most information transfer from the ICs to OTT occurs manually. The IC technology transfer offices communicate with each other only sporadically, relying on a broadcast email list or direct phone contact, even though it is fairly common for a single company to negotiate agreements with multiple ICs. Meanwhile, generating NIH-wide reports on technology transfer activities—for purposes that range from responding to Congressional inquiries to strategic planning to program evaluation—often involves hand-reconciliation of information obtained through separate inquiries to multiple offices.

In light of this lack of integration and other perceived concerns, the purpose of this Needs Assessment was to document and assess the information technology needs of the technology transfer community, with particular focus on the possible need for greater integration. Specific objectives included the following:

1. Characterize existing information technology solutions employed by the technology transfer community for tracking technology transfer agreements;

2. Identify areas of perceived need for additional information, communication or functionality, if any;

3. Identify potential strategies for meeting any identified needs;

4. Provide analysis leading to a recommendation regarding whether and how to move forward.

The Needs Assessment proposal was originally submitted by OTT on behalf of the entire NIH technology transfer community. The Science and Technology Policy Institute (STPI), a Federally-Funded Research and Development Center based in Washington, DC, was selected as the contractor. STPI’s work on the Needs Assessment was jointly overseen by OTT and TDC representatives.

2 Approach and Methods

The overall approach to the Needs Assessment was to collect information that would document existing information needs of the technology transfer community, current infrastructure for meeting those needs, and perceived gaps. Needs Assessment data collection consisted of interviews with the TDCs and OTT and review of available documentation for existing data systems.

Interview data collection took place in two parts. The Technology Development Coordinators (TDCs) at all of the ICs were invited to provide information about their systems and needs via a brief survey and more in-depth interview. Interviews were conducted in person or via telephone, with between one and three ICs participating in each. Representatives from a total of 13 ICs chose to participate (Table 1), including all of the ICs with independent data systems. In the case of several ICs with Competitive Service Centers, multiple interviews were conducted in order to more fully represent the range of perspectives.

Table 1: ICs that accepted invitations to participate in interviews for the Needs Assessment

| |ICs with Independent Data |ICs without Independent Data |ICs with Minimal Volume of |

| |Systems |Systems |Technology Transfer Activity |

|Participated |NCI, NHLBI, |CC, NIDCR, |NIBIB, FIC |

| |NIAID, NIDDK, |NIDA, NINDS | |

| |NHGRI, NIAAA, | | |

| |NIMH | | |

|Did not Participate |(none) |CIT, NCCAM, |CSR, NIGMS |

| | |NEI, NIA, NICHD, | |

| | |NIDA, NLM, | |

| | |NIDCD, NIEHS, | |

| | |NIAMS, NCRR, | |

| | |NINR | |

Similar interviews were then conducted with staff members at OTT, including representatives from the Division of Administrative Management, Division of Technology Development & Transfer, and the Competitive Service Center.

Preliminary findings were presented to both the TDCs and OTT staff members at group meetings in October and November of 2007, and feedback from both groups was incorporated into the final report. In several cases, follow-up interviews were then conducted with individuals at the ICs and at OTT who were most familiar with the existing data systems in order to confirm initial assumptions regarding feasibility of proposed options.

3 Structure of this Report

This report begin by describing the participants in the technology transfer community as identified through the Needs Assessment, as well as the existing information technology infrastructure used by those participants. The direction and nature of the most common and important flows of information between and among technology transfer data systems is also described. The next sections describe perceived needs for improved information technology as revealed through interviews with technology transfer community members. The final section presents the options that were considered for meeting perceived needs, as well as analysis of those options and STPI recommendations for how the NIH technology transfer community should move forward.

Technology Transfer Community, Existing IT Infrastructure, and Flow of Information

1 Technology Transfer Community Participants

The technology transfer community at NIH includes a large number of participants, both within NIH and beyond. Identifying the boundaries of the community was a critical first step for the Needs Assessment. Because the study focused on information technology, the primary criterion used to determine membership in the technology transfer community was whether the group in question possessed and/or required information on technology transfer agreements or processes. Within NIH, the following groups were identified as members of the technology transfer community:

• Intramural researchers. Intramural researchers become participants in the technology transfer system when they develop inventions or other intellectual property and/or when they enter into agreements with outside organizations to provide or accept information, resources, or services.

• Technology Development Coordinators (TDCs). Each IC has a designated individual (in many cases with an extensive staff) who is responsible for coordination of technology transfer activities for that IC.[1] The TDCs play a wide variety of roles in the technology transfer process, including negotiation and administration of agreements with research collaborators, review of Employee Invention Reports, and management of IC budgets for pursuit of intellectual property protection.

• Competitive Service Centers. NCI, NHLBI, and OTT each operate a competitive service center that provides assistance to the TDCs on management of technology transfer activities. Services provided vary by service center and client needs, but in most cases they include use of a common information system to track technology transfer activities and agreements.

• Office of Technology Transfer (OTT). A part of the Office of Intramural Research (OIR) in the NIH Office of the Director, OTT's mission is to evaluate, protect, market, license, monitor, and manage the wide range of NIH and FDA discoveries, inventions, and other intellectual property as mandated by the Federal Technology Transfer Act and related legislation. OTT is also responsible for the administration of royalties in conjunction with OFM.

• NIH Office of Financial Management (OFM). OFM is involved with technology transfer because it administers royalties and other payments received from licensees of NIH technologies.

• Internal oversight bodies. Other stakeholders in the technology transfer process include the NIH Ethics Program, which is charged with assisting staff in meeting requirements of the statutes and regulations governing the behavior of federal employees such as transparency and conflict of interest. Others, such as nurse coordinators, veterinarians, Institutional Review Boards, etc. may need access to information of technology transfer in order to fulfill their oversight responsibilities with respect to clinical trials and/ore research involving animal or human subjects.

In addition, the following external groups play important roles in NIH technology transfer processes:

• Research collaborators. This group includes corporations, academic institutions, and other extramural research organizations that enter into agreements with NIH intramural researchers to provide or accept information, resources, or services.

• Licensees. All parties who license intellectual property owned by NIH.

• Law firms and consultants. Firms and individuals providing legal or other services under contract with OTT, TDCs or the Service Centers.

• Patent authorities. Especially the US Patent and Trademark Office, equivalent bodies in the European Union and Japan, and other patent and intellectual property authorities worldwide as relevant.

2 Existing IT Infrastructure

TDC Data Systems

There are a total of seven independent technology transfer data systems maintained by the TDCs (Table 2), of which six are currently operational while one is still under development. Three of these systems (NIMH, NHGRI, and NIAAA) are relatively simple databases, built for the sole purpose of tracking and storing information relevant to the technology transfer agreements executed by the TDCs. The remaining systems are more sophisticated, with knowledge and workflow management features and capabilities that are custom tailored to the business process needs of their owners.

Table 2: TDC Technology Transfer Information Systems

|Owner |System Name |Software Platform |Maintained By |Knowledge Management |

| | | | |Capabilities and Other |

| | | | |Features |

|NCI |TIMS |FileMaker Pro 8.5 |Contractor |Yes |

|NIDDK |TechTracS |TechTracS (4D) |Knowledge Sharing Systems |Yes |

|NHLBI |TechTracS |TechTracS (4D) |Knowledge Sharing Systems |Yes |

|NHGRI | |Oracle |NHGRI staff |Minimal |

|NIMH |TRAN |Microsoft Access |OTT Competitive Service |Minimal |

| | | |Center[2] | |

|NIAID | |Wellspring |Wellspring |Yes |

|NIAAA | |FileMaker |NIAAA staff |Minimal |

NCI's TIMS data system is built on a FileMaker Pro 8.5 platform. Both NIDDK and NHLBI have independent systems built on the TechTracS platform, a modular intellectual property solution that was originally developed for NASA based on the 4D relational database management system.[3] The NIAID system, which was not yet in use at the time this report was finalized, is based on knowledge management solutions provided by Wellspring.[4]

Two of these more sophisticated systems, NCI’s TIMS and NHLBI’s TechTracS, are also used by the competitive service centers at those ICs to store and manage data for other TDCs, although it should be noted that not all agreements executed by service center clients necessarily end up in the service center databases.[5] An additional four ICs (CSR, FIC, NIBIB, and NIGMS) currently have minimal volume of technology transfer agreements and neither maintains an independent data system of their own nor makes use of the IT infrastructure provided by a competitive service center.

OTT Data System

OTT uses a TechTracS system based on the same modular technology as NHLBI and NIDDK (for clarity, we will refer to it as ‘OTT TechTracS’). OTT TechTracS includes modules for:

• Inventors

• Inventions

• Contacts

• CRADAs

• Patents

• Technologies

• Licenses

• Royalties

• Commercialization

• Invoices

Other Relevant Data Systems

OFM relies on the NIH Business System (NBS), an enterprise-wide data system used to manage a wide variety of financial transactions throughout NIH. The Needs Assessment did not explore the NBS system in detail, but it is relevant to the technology transfer community because it is used to track payments received from licensees.

Most law firms, licensees, and technology transfer partners also maintain independent data systems that include relevant information in electronic form. While the details and technical specifications for those systems were out of scope for this Needs Assessment, their existence is potentially significant because they may represent an untapped resource.

Existing Solutions for Data Transfer

There is currently no direct transfer of information among the seven TDC systems or between any of those systems and OTT, although plans are underway to allow limited transfer from OTT’s TechTracS system to the other TechTracS users (NHLBI and NIDDK) and to NCI.

For indirect transfer of certain information from OTT to the TDCs, the technology transfer community relies on a module of nVision, an NIH-wide data warehousing and reporting system. The nVision module for technology transfer was first implemented in 2004. Its advantages include an architecture designed for data warehousing and compatibility with other NIH enterprise systems. As currently implemented, however, the nVision solution for technology transfer was almost universally described as inadequate by users. Details are provided in the next section.

3 Flow of Information

Having defined the major players in the technology transfer community and the existing IT infrastructure, the next step was to characterize flows of information between community participants. In particular, STPI sought to identify:

1) Groups that routinely exchange information;

2) Content and format of the relevant information if predictable; and

3) Current mechanism(s) of information exchange.

Figure 1 maps the flows of information among technology transfer community members as identified by the Needs Assessment. As indicated in Figure 1 by dashed arrows, certain information flows were considered out of scope for the Needs Assessment either because they occur outside of the domain of NIH control (e.g. submission of patent applications to the USPTO) or because the content and nature of the interactions are sufficiently specialized that it would be neither practical nor desirable for such interactions to be centrally coordinated (e.g. interactions between intramural researchers and their collaborators).

Figure 1: Map of information flows among members of the technology transfer community. Dashed arrows indicate information transfer considered out of scope for the Needs Assessment. Colored boxes indicate community members who are part of the NIH community, while white rectangles represent extramural participants.

As might be expected, the web of interactions is quite complex, with most technology transfer community members exchanging information with most others on a regular basis. An effort was also made to understand the nature of the information transferred in each of these interaction types. However, given this complex web of interactions, it was not considered feasible to account for every possible exchange of information; rather, the goal was to characterize the most common and important instances of information flow. In particular, STPI focused on characterizing exchanges of information that would be most suitable for electronic transfer in a structured format.

Tables 3a-d summarize the types of information exchanges identified by the Needs Assessment. Table 3a focuses on exchanges between OTT and the TDCs, the majority of which occur through email or personal contact, with nVision accounting for information flow from OTT to the TDCs regarding the IC patent and license portfolios. Tables 3b and 3c describe information exchanges between the TDCs and OTT with partners other than each other or OFM; in the case of OTT and most of the TDCs, such information transfers tend to be manual via email, but some TDCs have more automated mechanisms for information transfer in place. Finally, Table 3d describes information transfers to and from OFM, few of which are automated with the exception of information transferred via nVision.

Table 2a: Transfer of Information Between OTT and TDCs

|Information Transferred |Direction of Transfer |Method of Transfer |

|Patents and Licensing | | |

|Patent and license portfolio contents |OTT to TDCs |nVision followed by manual data entry |

|Cost information for patent and licensing |OTT to TDCs |nVision followed by manual data entry |

|activities by OTT | | |

|Notification of significant changes (e.g. |OTT to TDCs |Email followed by manual data entry |

|patent/license termination) | | |

|Recommendation memos and |Bi-directional between OTT and TDCs |Email followed by manual data entry |

|concurrence/non-concurrence by TDCs | | |

|Reminders for important dates |Bi-directional between OTT and TDCs |Email |

|Reporting possible infringement claims |TDCs to OTT |Email |

|Royalties and Other Income | | |

|New executed licenses |OTT to TDCs |Email |

|Royalties distribution |Tri-directional from OTT to TDCs and OFM |Email followed by manual data entry |

|form/changes/approval | | |

|CRADAs and Other Agreements | | |

|CRADA clearance sheets/changes/approvals |Bi-directional between OTT and TDCs |Email followed by manual data entry |

|Notification of changes to CRADAs |TDCs to OTT |Email followed by manual data entry |

|Updates on CRADA partner status and contact|TDCs to OTT |Email followed by manual data entry |

|information | | |

|Counts of MTAs, CTAs, and CDAs |TDCs to OTT |Email |

|Inventors and Inventions | | |

|Submission of Employee Invention Reports |TDCs to OTT |Email followed by manual data entry |

|Updates on inventor status (e.g. death) and|TDCs to OTT |Email followed by manual data entry |

|contact information | | |

Table 3b: Transfer of Information between TDCs and groups other than OTT or OFM

|Information Transferred |Direction of Transfer |Method of Transfer |

|Negotiations of terms for CRADAs, MTAs, |Bi-Directional between TDCs and Research |Email, Phone, or Personal Contact |

|CTAs, CDAs, and other agreements |Collaborators | |

|Status updates, changes in contact |Research Collaborators to TDCs |Email or Phone and manual data entry |

|information, etc. | | |

|Initial submission and review of EIRs |Bi-Directional between TDCs and Intramural |Email followed by manual data entry |

| |Researchers | |

|Status updates on CRADAs, MTAs, CTAs, |TDCs to Intramural Researchers |Varies by TDC; some allow direct access to |

|patents, licenses, royalties, etc. | |data systems, others provide updates by |

| | |email or upon request |

|Information on patent/license portfolios |Lead TDC to Other TDCs |Email, Phone, or Personal Contact |

|and costs for collaborative technologies | | |

|Terms of agreements with particular |Bi-Directional Between TDCs and Other TDCs |Email, Phone, or Personal Contact |

|companies and other information to assist | | |

|in ongoing negotiations | | |

|Human subjects-related information, |TDCs to nurse coordinators, veterinarians, |Varies by TDC; some allow direct access to |

|animal-subjects related information, and |and ethics personnel |data systems, others provide updates by |

|conflicts of interest | |email or upon request |

Table 3c: Transfer of Information between OTT and groups other than TDCs or OFM

|Information Transferred |Direction of Transfer |Method of Transfer |

|Reporting possible infringement claims |Intramural Researchers to OTT |Email, Phone, or Personal Contact |

|Negotiation of terms for licenses |Bi-directional between OTT and Licensees |Email, Phone, or Personal Contact followed |

| | |by Manual Data Entry |

|Licensee “welcome package” |OTT to Licensees |Email and Hardcopy |

|Payment notices, reminders |OTT to Licensees |Email |

|Sales reports |Licensees to OTT |Email |

|Work orders and invoicing |Bi-directional between OTT and Law Firms |Email and Hardcopy |

|Correspondence on patent applications, |Bi-directional between OTT and Law Firms |Email or Hardcopy |

|other patent documents | | |

|Reminders for due dates |Law Firms to OTT |Email |

|Updates to contact information |Research Collaborators, Licensees, and |Email followed by manual data entry |

| |Intramural Researchers to OTT | |

Table 3d: Transfer of Information between OFM and Others

|Information Transferred |Direction of Transfer |Method of Transfer |

|Notification of payments received from |Bi-Directional between OTT and OFM |Email or personal contact |

|licensees (for account reconciliation) | | |

|Notification of payments received from |OFM to TDC |nVision |

|licensees | | |

|Instructions for distribution of royalties |OTT to OFM |Email |

|and other payments | | |

|Debt-collection alerts |OFM to OTT |Email or personal contact |

|Submission of royalties and other payments |Licensees to OFM |Mail or electronic |

|Distribution of royalties and other |OFM to Intramural Researchers, Research |Mail or electronic |

|payments from licensees |Collaborators | |

|Updating contact information |Licensees, Intramural Researchers, and |Email |

| |Partners/Collaborators with OFM | |

Areas of Perceived Need

Interviews with stakeholders suggested four broad categories of perceived needs for improvement in information technology for the technology transfer community:

1) No net loss of functionality or productivity;

2) Desired improvements to existing systems;

3) Improved information transfer between existing systems;

4) Miscellaneous other needs and issues.

Details regarding specific needs as expressed by stakeholders are described below.

1 1. No Net Loss of Functionality or Productivity

Virtually every technology transfer community member interviewed, including participants from both OTT and TDC offices, expressed strong concerns about maintaining current data, functionality, and levels of productivity. They also emphasized the need for adequate long-term planning and a strong commitment to any proposed information technology solution. The vehemence with which these concerns were expressed suggested to STPI that they may have been motivated by more than simple conservatism, and several interviewees went as far as to cite past experience with updates to existing systems and information technology solutions being imposed from above without adequate consultation or planning were cited frequently as the source of these concerns. As those experiences are not directly relevant to the current Needs Assessment, they were not explored in detail, but the existence of widespread misgivings about new information technology solutions in the technology transfer community is a factor that must be taken into account. Specific needs expressed by community members are described below.

1.A Current functionality, business rules, and legacy data should be preserved.

The four ICs with the highest volume of agreements and most sophisticated information systems (NCI, NHLBI, NIAID, NIDDK) emphasized that they would not be willing to give up any of the functionality provided by their current systems. Examples mentioned included automated reminders, workflow management features, control over read/write privileges, auto-population of forms, security features, etc. Several TDCs also mentioned that they have the backing of their ICs’ leadership in insisting that functionality for which they had already invested time and effort was not lost. Similar concerns were echoed by OTT staff members, who warned that the complicated business rules that underlie TechTracS would be extremely difficult to replicate and that migrating legacy data to a new system might pose a significant challenge.

1.B Existing differences in business processes should be accommodated.

A related point mentioned frequently is that there exist differences in business processes among the ICs that any new system would have to be designed to accommodate. One concrete example given is that, in some IC technology transfer offices, the information system routes copies of all patent-related email to the director. At other ICs, however, volume of mail is such that this would flood the director’s mailbox; certain management/oversight responsibilities are therefore delegated to others. Any successful new system would have to be flexible enough to accommodate such differences in workflow.

1.C Any changes must be designed, implemented, and launched in a manner that minimizes loss of productivity.

Many ICs expressed apprehension about the potential loss of productivity involved in upgrading or switching over to any new system, and this sentiment was most pronounced at ICs with the largest volume of agreements and number of staff members. They stressed that the costs associated with re-training and disruptions in productivity can be prohibitive, even though they are relatively short-term. Several pointed to past experience with painful transitions or upgrades, where time, money, and in some cases even data had been lost. There seemed to be general consensus that a great deal of planning would be needed to ensure that any necessary transition would be smooth; ideally, any new system would be implemented in a manner that increases productivity immediately so the benefits would be self-evident. Other TDCs pointed out the importance of planning for long-term continuity and adaptability to accommodate changes in technologies, business practices, and/or the laws governing technology transfer.

2 2. Improvements to Existing Data Systems

Stakeholders described a number of deficiencies in the existing TDC and OTT data systems that they would like to see corrected. Those perceived needs that were judged to be sufficiently broad in scope to be of general interest are described below.

2.A Improvements to TDC systems should continue to reflect internal priorities.

Three of the four ICs with the most substantial investment in their technology transfer data systems (NCI, NHLBI, and NIDDK) have been actively working to improve their data and knowledge management systems, while the fourth (NIAID) is in the process of building an entirely new system. For example, NHLBI and NIDDK are coordinating efforts to incorporate data directly from OTT TechTracS and to add links to the NIH Enterprise Directory. In 2005, NCI commissioned an independent needs analysis to identify priorities and make recommendations for future improvements to the TIMS system. Representatives from all four of these ICs indicated that they have well-defined priorities and are working to make improvements to meet their internal needs. They indicated that the primary limiting factor is budgetary.

2.B Some technology transfer agreements are not currently captured by any existing data system.

It is important to note that there are at least two categories of technology transfer agreements that are not believed to be captured by any existing data system. First, four of the ICs with minimal volume of technology transfer activity (CSR, FIC, NIBIB, and NIGMS) neither maintain independent data systems nor use a service center. Any technology transfer agreements these TDCs enter into therefore occur beyond the reach of the technology transfer community's existing IT infrastructure. The second category of agreements that may not be captured are agreements handled independently by TDCs that rely on the competitive service centers to assist with some but not all of their technology transfer activities. Interviewees expressed concern that an unknown number of agreements executed independently are not captured by the existing data systems.

2.C A number of specific improvements could be made to OTT TechTracS.

Interviewees at OTT voiced a number of concerns specific to OTT TechTracS, several of which could potentially have relevance for large parts of the technology transfer community. Briefly, suggested upgrades with general relevance included the following:

• Web-enabled interfaces to allow users beyond OTT (e.g. TDCs, licensees, law firms, OFM) remote access to view and upload information;

• Improved ability to organize, sort and/or search for information within attachments;

• Improved ability to create and export user-generated reports;

• Additional automated features for checking data quality and internal validity;

• Links to the NIH Enterprise Directory in order to standardize identity management.

Suggested upgrades that would be more limited in scope, but might still drastically improve efficiency for particular user groups at OTT, include:

• Addition of an embedded “help” feature;

• Simplified task-specific interfaces for OTT users;

• New modules for audits and patent interference;

• Addressing issues with auto-population of data between certain modules (e.g. earned royalty rates);

• Addressing issues with certain automatic calculations (e.g. patent prosecution cost calculation);

• Improvements in the system for recording the location of paper files.

3 3. Improved Information Transfer

Identification of needs regarding transfer of information between technology transfer data systems was a priority of the Needs Assessment. Virtually all of the interviewees agreed that needs exist in this area, but priorities tended to vary according to role. STPI therefore identified a set of overarching needs (3.A-C below) as well as a set of specific priorities for content of information to be transferred as described by interviewees.

The following specific information transfer needs were mentioned most frequently as priorities by interviewees from the TDCs:

• Timely status updates for ongoing negotiations and other OTT activities;

• Frequently updated and easily accessible information on the content of IC technology, patent, and license portfolios;

• Improved information on IC expenditures for patent/licensing activities, by technology/inventor, in order to facilitate cost analysis;

• Improved information on receipt of royalties and other income from licensees.

Priorities for information transfer as expressed by interviewees from OTT included:

• Notification of TDC activities including MTAs, LOIs for CRADAs, and marketing efforts;

• Notification of updates to CRADAs with potential to impact license obligations or royalty distribution;

• Streamlining of certification and approval processes involving other members of the technology transfer community (e.g. royalties distribution);

• Improved person-tracking abilities, including disambiguation and updates to contact information;

• Contractual and technical facilitation of electronic exchanges with law firms.

3.A As currently implemented, the nVision reporting solution is not adequate for transfer of information between data systems.

The current solution for transferring information from OTT to the TDCs, using the enterprise application nVision, was unanimously described by the TDCs as inadequate. On a weekly basis, the nVision system takes certain relational data exported from OTT TechTracS, strips the relational information, and stores the simplified data as part of the NIH-wide data warehouse. The information can then be accessed by the TDCs through the nVision system interface.

Specific complaints about the nVision solution included the following:

• Data are not posted and updated with sufficient frequency and transparency;

• The output format is neither intuitive to understand nor easy to work with;

• Relational information is lost needlessly in “flattening” process;

• nVision staff do not provide adequate support or notification of changes.

The ICs that are current users of TechTracS (NHLBI and NIDDK) and NCI are in the process of implementing functionality that allows them to import data directly from OTT TechTracS. Solutions available to the other ICs range from manual re-entry from paper printouts or .pdf’s to complicated conversion processes which must be revised every time nVision makes a change. The TDCs unanimously agreed that information should be provided electronically and in a format that does not require manual re-entry.

3.B Unnecessary manual data entry and re-entry should be eliminated.

The Needs Assessment identified several examples of situations in which data that exist in electronic format in one data system are routinely manually re-entered into another data system. Examples include:

• EIRs and CRADAs submitted by the TDCs to OTT

• Portfolio and financial data from OTT and OFM to TDCs

• Royalties distribution information from OTT to OFM

• Sales reports from licensees to OTT

• Invoices sent from law firms to OTT

Stakeholders expressed concerns about manual data re-entry because it wastes scarce labor resources, slows down the processing of information, and increases probability that errors will be introduced during the transcription process. They suggested that a combination of web interfaces, standardized reporting, and automatic transfer protocols might greatly improve efficiency and accuracy of information transfer.

3.C Create a centralized data resource for non-proprietary information regarding technology transfer agreements and other information.

Interviewees from the TDCs indicated that there is a need to more easily facilitate sharing of information about the existence of technology transfer agreements and negotiations throughout the technology transfer community. Currently, the only means of sharing information about the existence of agreements is through broadcast email or personal contact; no centralized data source is available for querying. A TDC preparing to negotiate an agreement with a new research collaborator may therefore be unaware of previous dealings that partner has had with other TDCs or with OTT. Potential problems that may arise from this situation include research partners “shopping around” to find the IC willing to give them the most favorable agreement terms. TDCs also expressed frustration at being unprepared to answer questions from negotiating partners who expect NIH to present a united front.

Similarly, OTT interviewees expressed a desire to compare notes with the TDCs regarding their interactions with potential licensees, describing the knowledge of the experiences of the TDCs as valuable market research. Under the current system, however, OTT staff members also must resort to broadcast emails to identify individuals at the TDCs with relevant knowledge.

Most interviewees from both OTT and the TDCs agreed that it would be useful to create a centralized data resource in order to share enough information about the existence and status of negotiations and agreements so that it would at least be clear who to contact for more information. Some interviewees indicated that they would be willing to share specific terms of the agreements and other details as well, but others felt that it would be sufficient to alert users to the existence of agreements and point them towards a responsible individual for more information. If created, such a centralized data resource might also act as a centralized repository for shared forms, guidelines, policies, training modules, etc.

4 4. Policy and Process Issues

In addition to the technical information technology needs described above, interviewees also raised a number of issues and concerns related to information technology policy and process. Although they likely do not constitute independent information technology needs in their own right, several of these issues are worth noting because of their potential to constrain or otherwise impact future information technology decisions. These issues are described briefly below.

• Business process differences. The existence of differences in business processes between different TDCs and OTT was cited frequently as an argument against the feasibility of a single, unified enterprise data system. It is not clear, however, how many of these differences serve a specific purpose and how many are simply stylistic or artifacts of historical decisions. If the technology transfer community is willing, these issues might productively be explored in the context of long-term planning for information technology.

• Handling of electronic documents and signatures. Interviewees almost universally expressed a desire to reduce the number of transactions requiring paper copies and signatures, but many expressed reservations regarding the acceptability to NIH of electronic signatures. This is an important policy question with clear potential to impact long-term planning for technology transfer information systems.

• Control of data and conflict resolution. Several interviewees raised concerns regarding data curation practices, which vary among the ICs and OTT. A related set of concerns surrounded the issue of how disputes would be resolved and who would have ultimate control over pooled data. For instance, if one community member found errors or inconsistencies in the information provided by another, could the data be overwritten without the provider’s consent?

• Information security and access to information. Interviewees raised a range of concerns related to both information security and access to information. Some concerns, such as the need for appropriate access controls to protect confidential information, were uncontroversial, while others were limited to particular groups. For example, some interviewees expressed concerns that, were it to be widely known that NIH technology transfer data were being aggregated in one place, it might encourage inappropriate requests for business confidential information under the Freedom of Information Act. Perhaps more plausibly, others worried that centralized information might be misinterpreted or taken out of context. Stakeholders will have to be comfortable with information security and access policies prior to the implementation of any new information technology solutions.

• Facilitating collaboration. There appeared to be a sense among the TDCs that OTT should make an effort to remove unnecessary administrative obstacles to collaboration among multiple TDCs with respect to technology transfer. The examples cited most often are that OTT does not allow work order costs to be split among multiple ICs and that only the designated “lead” collaborator has access to information on patents and licenses arising from collaboratively developed technologies. While acknowledging that these limitations exist in TechTracS, interviewees at OTT appeared to view facilitating collaboration as the administrative responsibility of the TDCs. An agreement on how best to handle collaborative technologies would be useful for information system planning purposes.

• Information technology portfolio analysis. Finally, several TDCs described development of additional analytic capabilities for technology transfer portfolio data as desirable. For example, some interviewees expressed the desire for software tools to facilitate thematic analysis of their technology portfolios for marketing purposes. Others described a need for tools to help analyze the return on investment for patenting and licensing particular types of technologies. The possibility that technology transfer data might someday serve as inputs to such analyses should be accommodated in the design process for future systems.

Analysis and Recommendations

Four high-level options were considered in order to meet the information technology needs identified by the Needs Assessment. This section describes those options in detail. It then describes the criteria that were developed to evaluate those options as well as STPI's recommended option.

1 Options for Meeting Need

Option 1: “Laissez-faire” approach

The first option considered for meeting needs was to maintain the status quo. This option would have the advantage of meeting the first set of identified needs for no net loss of information or functionality. Internal issues with existing systems would be addressed by individual system owners according to their own priorities as time and funding permit. Information transfer needs would likely continue to be met using “work-around” solutions such as nVision conversion utilities and manual data dumps. The possibility of giving all TDCs limited but direct views into OTT TechTracS has been discussed, and this would be an inexpensive but significant short-term improvement.

Option 2: Targeted improvements to existing architecture

The second option considered was to leave the existing information technology architecture in place but to make targeted upgrades in order to meet specific needs. Suggested upgrades are described below.

A) Create web-based interfaces to OTT TechTracS with views customized for all appropriate user groups. This upgrade would help to meet a number of identified needs, including reducing reporting lag time and allowing “silent” status checks by the TDCs and other stakeholders such as inventors, partners, licensees, etc. It could also be used to facilitate web-based submission of documents, notification of payments, updates to contact information, and automated routing of information for approval.

B) Introduce automatic information transfer between OTT TechTracS and IC systems. The goal here would be to reduce the need for manual re-entry of information that already exists in electronic format in another system. The main TDC data systems and OTT TechTracS would automatically export and import a mutually agreed-upon list of common data elements on a regular schedule (perhaps nightly). Business logic could be added to notify appropriate users of updates or flag discrepancies for reconciliation. In order to be practical, this solution would require that all technology transfer community members use an electronic data system and agree upon definitions for critical data elements. The existing nVision data warehousing solution would be one option for implementation, with the advantage of being already integrated with other NIH enterprise systems. However, if the nVision staff does not have the time or resources to assist with this project, a new system could be built from scratch, most likely using a “hub-and-spokes” model for system architecture.

3. Create a shared “situational awareness” website and database for non-proprietary information. This upgrade would provide the entire tech transfer community with access to non-proprietary information on existing agreements, ongoing negotiations, and selected other activities. Conceivably, this website could allow queries against a subset of the information captured centrally through the automatic information transfer solution described above, although appropriate measures would have to be taken in order to ensure information security. The website might also be convenient as a central repository for shared forms, reports, announcements, or other information.

4. Make specific additional improvements to existing OTT TechTracS. The Needs Assessment identified a number of additional upgrades to OTT TechTracS that would likely increase productivity. Among the most frequently cited priorities were the need to improve user-defined reporting and the ability to sort or search within attachments. While far from trivial, these and other issues could be addressed individually

Option 3: Purchase and configure TechTracS for all ICs

Under this option, each IC or competitive service center would adopt a customized version of TechTracS. Web interfaces and transfer utilities would still be desirable to facilitate transfer of information between systems, but use of a single platform would significantly improve compatibility. While it would probably meet the identified needs, this solution would likely be unacceptable to those TDCs with substantial investments in other systems because of very high transition costs and for other reasons. Current TechTracS users who have built systems using internal funds might have concerns on the basis of equity. Finally, because of the large amount of customization required to mimic the functionality of at least five existing systems in addition to the need to build web interfaces and transfer utilities, this option would be extremely costly.

Option 4: Build new, fully-integrated enterprise system

The final option proposed for meeting identified needs was to build from scratch a new enterprise system that would encompass most or all of the technology transfer community, including NIH and external participants. A case could likely be made for using either TechTracS/4D or a more common relational database management system (RDBMS) as the platform. Depending on how it was implemented, this solution could potentially meet all of the functionality needs identified in the Needs Assessment. However, concerns were voiced at both OTT and the TDCs about the long and intensive planning process that would be required, potential productivity losses involved in training staff on a new system and converting legacy data, the possible need to eliminate differences in business practices, and the fact that the project might be prohibitively expensive.

2 Analysis of Options

For the purpose of evaluating the proposed options, STPI developed four criteria:

1) Degree to which the proposed option would provide additional functionality required to meet identified needs;

2) Anticipated cost to build and implement;

3) Anticipated cost to maintain and upgrade;

4) Perceived acceptability to the entire technology transfer community.

Table 4 describes STPI's analysis of options using the criteria is presented in the form of a matrix. Because accurate estimates of cost and functionality would require fairly detailed design specifications that were not within the scope of the Needs Assessment, the first three criteria were used to assess each option relative to the other options rather than absolutely. The fourth criterion, perceived acceptability, was initially applied somewhat subjectively based on STPI's best guess of likely attitudes because not all of the options had been defined in detail when the initial interviews took place. These guesses about stakeholder attitudes were then confirmed by the reactions of stakeholders when preliminary data and options were presented in October and November of 2007.

Table 4: Analysis of proposed options using criteria developed for the Needs Assessment.

|  |Gains to functionality |Cost to implement |Cost to maintain and |Perceived |

| | | |upgrade |acceptability |

|Option 1: Laissez-faire |Incremental gains, no |None |Moderate |Moderate |

| |losses | | | |

|Option 2: Targeted |Specific gains, no |Moderate |Moderate |High |

|improvements to existing |losses | | | |

|architecture | | | | |

|Option 3: Purchase and |Broad gains, potential |High |Low |High for current |

|configure TechTracS for all |for some losses | | |users; Low otherwise|

|ICs | | | | |

|Option 4: |Broad gains, potential |High |Low |Low |

|Single, fully-integrated |for some losses | | | |

|enterprise system | | | | |

3 Recommended Option

Based on the analysis described above, STPI recommends that the technology transfer community pursue Option #2 in the medium term. This option offers a moderate potential to meet information technology needs with little risk of losses and comparatively moderate costs to build and implement. Its perceived acceptability to all technology transfer community members was also rated the highest.

In the long term, however, the technology transfer community should aim to evolve towards greater integration of information systems. Meeting both medium and long term goals will require careful planning, with explicit attention paid to make design choices that maximize potential for interoperability. The technology transfer community may also wish to consider ongoing discussions to resolve non-technical issues, such about the reasons for existing differences in business practices and explore opportunities for future coordination

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[1] Names and contact information for the current TDCs can be found at .

[2] The OTT Competitive Service Center maintains the TRAN database as a repository for NIMH information only. TRAN was originally built and administered by NIMH contractors. There are no current plans to merge TRAN with OTT TechTracS.

[3] For more information on TechTracS, see . Accessed 2/22/08.

[4] For more information, see . Accessed 2/22/08.

[5] NCI service center clients include: CIT, CC, NCCAM, NEI, NINDS, NIA, NICHD, NIDCR, NIDA, and NLM. NHLBI service center clients include: NIDCD, NIEHS, NIAMS, NCRR, and NINR.

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